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Improving information for research participants - a blog by Leni Sivey

Last updated on 16 Dec 2021

Through Think Ethics, we are continuing our work to put participants and ethics at the heart of health and social care research. Our Ethics Review Advisory Group is meeting this week (Friday 17 December). Here Leni Sivey, Public Involvement Manager, talks about their work to make sure people invited to take part in research receive clear and concise study information which has been designed with and for patients and study participants.

Leni Sivey looking at the camera stood in front of a brick wall

‘Deciding to take part in health and social care research can be a big decision for many people, and it needs to be the right one for them. As a society we depend on people agreeing to take part in research every day - whether it be to test a new cancer drug, a COVID-19 vaccine or look at methods to improve dementia care or help prevent miscarriage. Therefore, we’ve been thinking a lot lately about what people want and need to know about research when deciding whether or not to take part in it – and how to share that information.

As part of Think Ethics, we’re trying to improve the quality of participant information, and to rethink how ethics committees review it.

Along the way we’ve spoken to patients and the public, ethics committee members, researchers and sponsors to find out where people see opportunities for improvement. At the same time, we’ve been taking a look at the evidence about what makes a difference to the effectiveness of information and consent documents and processes. What matters most in practice to determine whether people understand the information, whether they’re satisfied with it, and whether they use it?

Some of the evidence confirms a lot of what people involved in designing, reviewing, delivering, and using participant information told us: participant information sheets are long, and getting longer. This is particularly true for clinical trials and medical device studies. They are very often written in language that is too complicated and technical to do a good job of explaining the research clearly.

However, lots of people make their decision about whether to take part in research without using the participant information sheet. When people are given the power to choose how much information to have about a study, most seem to choose very little or no information.

Think Ethics: A diverse group of cartoon people including people who use a wheelchair, walking aids and people of different age and ethnicity with colourful speech bubbles above their heads

'Does that surprise you? It surprised me, but I’ve noticed that that doesn’t seem as unexpected to the public contributors or research delivery staff who I’ve been working with – and those two groups of people also seem to be underrepresented in the academic literature about information and consent. So we’re going to make sure that participants and patients are at the heart of how we develop ideas to improve information and consent.

Meaningful public involvement in participant information development and a high-quality consent conversation are the two factors which seem to make the biggest difference to how well people understand and retain information about a study they’ve been invited to join.

I have seen time and again how committed ethics committee members are to trying to be as sure as possible that everyone who is invited to take part in health and social care research in the UK ends up making the right choice for them. Choosing to take part in research goes far beyond reading an information sheet and signing a consent form; it’s a decision people make over and over again at every stage in the research journey. Ethics committees need to be confident that research participants will know when and how they can obtain information, ask questions or change their minds once they’ve started taking part in a study.

Participant information sheets are currently a really important part of ethics committee review, because they are a key indicator for whether the research is going to be explained to people in a way that’s clear, accurate, equitable and respectful.

However, an information sheet is a document which often stands in as a proxy for a process – the conversation between a potential participant and research delivery staff. Perhaps there are other ways that sponsors and ethics committees can take assurances about what will happen during this interaction between people in what is usually a very different context from the discussion at an ethics committee meeting?

Next steps

We’ve gathered evidence and heard some really useful feedback already. Now, working with our Ethics Review Advisory Group, we’re going to develop some potential options to help improve information and consent. We will then work with patients and the public, researchers, sponsors, research delivery teams, and ethics committee members to decide what the most effective way forward is to make sure that participant information is high quality, responsible, and effective. 2022 is going to be an exciting year and we can’t wait to share more about this work.’

UK Clinical Research Recovery, Resilience and Growth

Strengthening patient, public and service user involvement in research and enhancing our review programmes form part of seven areas of action in the UK Clinical Research Recovery, Resilience and Growth Programme which published its six-month review this week. The HRA is part of a UK-wide cross-sector partnership working to continue to set the global standard for good practice in public involvement in research design and management. This will ensure the public, patients and service users are increasingly able to contribute to clinical research, and that researchers are supported to work effectively with them.

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